Dissolution universal strategy tool (DUST): A tool to guide dissolution method development strategy

Abstract

Development of a dissolution method with suitable acceptance criteria is a key part of any oral drug products control strategy. As a key quality control test linked to safety and efficacy, dissolution strategy is often subject to extensive discussion during product development and with regulatory authorities during filing of the marketing application. A project review was recently performed at AstraZeneca to capture learning from dissolution method development and regulatory interactions from the last 10 years. The output of this review was distilled down to a few key messages that were critical to be considered when conducting dissolution method development. These key messages were then used as the building blocks for the Dissolution Universal Strategy Tool (DUST), that became part of the internal process at AstraZeneca for developing dissolution methods and acceptance criteria. The DUST can be used at all stages of product development and can be applied regardless of BCS Classification. The tool provides a common framework for cross-functional discussions, ensuring that project teams have a clear expectation of the role(s) of dissolution testing in drug product development, and that the understanding built during development will evolve into a suitable and clinically relevant QC test and acceptance criteria at time of submission which ensure the product will meet the patient’s requirements.